ABSTRACT
The Laboratory of Dutch Pharmacists determines LVP particulate matter contamination of LVPs produced in Dutch hospital pharmacies. The investigated LVPs must conform to the NVZA/LNA criteria, which prescribes eight samples and sets limits for particles > or = 2 microns, > or = 5 microns, > or = 10 microns, and > or = 25 microns for both mean and mean + 2x standard deviation. LVPs produced in 500 mL glass containers or plastic containers mostly met the NVZA/LNA criteria, but LVPs produced in 100 mL glass containers showed higher levels of particulate matter contamination. The composition of the LVP significantly affected the extent of particulate matter contamination, but the effect was relatively small when compared to the influence of the type of container. LVPs produced in Dutch hospital pharmacies and LVPs obtained from pharmaceutical industries showed comparable amounts of particulate matter contamination.
Subject(s)
Drug Contamination , Pharmaceutical Solutions/standards , Pharmacies/standards , Infusions, Parenteral , Netherlands , Particle Size , Pharmacy Service, Hospital , SolutionsABSTRACT
Reproducible particle counting using the light-obscuration technique is often troublesome because no absolute standard is available. Therefore, at the Laboratory of Dutch Pharmacists the "calibration-in-time" method was developed. This method enables checking of the amount of particles counted from a diluted latex suspension as a function of time. A particularity of the method is the one-step dilution procedure. The calibration-in-time method is compared with the particle-counting accuracy test according to the USP < 788 >. Advantages and disadvantages of both methods are discussed.
Subject(s)
Infusions, Parenteral/standards , Pharmacy Service, Hospital/standards , Suspensions/standards , Calibration , Drug Contamination/prevention & control , Latex/chemistry , Netherlands , Particle Size , Quality Control , Reproducibility of Results , Solutions/analysis , Solutions/standards , Sterilization/standards , Suspensions/analysis , Therapeutic Irrigation/standardsABSTRACT
A standard procedure, consisting of two TLC systems, for the qualitative control of creams is presented. All common cream excipients, except those of very high polarity, are separated in a simple gradient elution system, using diethyl ether as the eluent in a chromatographic chamber saturated with n-pentane. The very polar cream base components are separated using n-butanol-glacial acetic acid-water (20 + 2 + 5) as the eluent. The chromatographic behaviour of common cream excipients as well as three FNA cream bases and four commercial cream bases is discussed.
Subject(s)
Chromatography, Thin Layer/methods , Emulsions/analysis , Excipients/analysisABSTRACT
A standard TLC procedure was tested for its applicability in the qualitative analysis of several creams. It was found that in creams of known composition the presence of almost all of the active cream components as well as the excipients can be confirmed. An additional eluent, spray reagent, or a liquid extraction clean-up step sometimes appeared to be necessary. If the cream base composition is not known, a 'fingerprint' of the various types of excipients is obtained with the described procedure.
Subject(s)
Chromatography, Thin Layer/methods , Emulsions/analysis , Adrenal Cortex Hormones/analysis , Excipients/analysisABSTRACT
The possibilities of applying reversed-phase high performance liquid chromatography to the analysis of o/w emulsion type creams without preceding sample clean-up were investigated. The chromatographic behaviour of cream base components and active compounds in reversed phase systems consisting of methanol-water mixtures as the mobile phase and a chemically bonded octadecyl stationary phase, was studied. A number of active compounds and the preservative (sorbic acid) could be determined--often in one chromatographic run--without complications, by simply dissolving the sample in a suitable solvent mixture and injecting an aliquot of the solution into the chromatograph. Separation was achieved by the proper choice of methanol content, pH and ionic strength of the eluent. The compounds were detected by UV absorption. Some of the lipophilic cream base components could easily be determined in the same manner, with methanol as the eluent and with refraction index detection. The developed procedure was applied to the analysis of a number of creams. Some of the results are presented as examples, demonstrating the suitability of the method for quality control purposes.
Subject(s)
Ointments/analysis , Adrenal Cortex Hormones/analysis , Chromatography, High Pressure Liquid/methodsABSTRACT
The analysis without prior sample clean-up of promethazine hydrochloride or clioquinol in commercially available creams has been investigated using UV-spectrophotometry and titrimetric methods. The results were compared with those obtained by GLC and HPLC. Although in some cases the active drug could be determined satisfactorily using the comparatively non-selective UV-absorbance or titrimetric methods, these methods were found to be reliable only when applied to creams for which the qualitative and quantitative composition was completely known. Without prior sample clean-up, these methods will therefore be of interest mainly for process control purposes in manufacturing.
ABSTRACT
The possibilities for the determination of active components in creams by acid-base titrations in non-aqueous solvents were investigated. Interference by cream-base components with the titration of weak organic bases and their halides with perchloric acid in acetic acid, and with the titration of weak acids with tetrabutylammonium hydroxide in N,N-dimethylformamide were studied. It appeared to be possible to determine alkaloid halides, salicylic acid, hexachlorophene and methyl salicylate without previous clean-up of the cream samples.
